Type 1 Diabetes Clinical Trial
Official title:
Phase 2 Study Examining the Effect of Simvastatin vs Placebo on Monocyte Function and Inflammation in Patients With Type 1 Diabetes
Type I diabetes (T1DM) is associated with an increased risk of vascular complications. While
the precise mechanism(s) by which diabetes accelerates atherosclerosis has not been
elucidated, several lines of evidence point to the role of increased inflammation in the
pathogenesis of these vasculopathies. The monocyte-macrophage is a pivotal cell in
atherogenesis and is readily accessible for study. However, there is scanty data on monocyte
function and inflammation in T1DM. Simvastatin, a HMG-CoA reductase inhibitor, has recently
been shown to reduce cardiovascular events in diabetic patients (T1DM and T2DM in the Heart
Protection Study). Recent studies demonstrate that simvastatin decreased C-reactive protein
and decreased pro-atherogenic activity of monocytes in non-diabetic subjects. However, there
is a paucity of data on the effect of simvastatin on inflammation and monocyte function in
Type 1 diabetes.
Thus, the purpose of this study is Aim 1) to assess biomarkers of inflammation in T1DM
compared to matched controls (n=50/group). Aim 2) Also, we will assess the effect of
simvastatin (20mg/day) therapy on inflammation and monocyte function in T1DM in a
randomized, placebo-controlled, double blind trial.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Type I diabetic patients (onset < 20years and on insulin therapy since diagnosis) without clinical macrovascular complications, present age > 20 years with duration of diabetes > 1yr. Exclusion Criteria: - HbA1c over the last year >10% - Patients on glucophage and/or the thiazolidenediones will be excluded, since these drugs appear to be anti-inflammatory. - Theumatoid arthritis; - Abnormal liver function, - Hypo- or hyperthyroidism; - Malabsorption; - Steroid therapy, - Anti-inflammatory drugs except aspirin (81mg/day) - Pregnancy, - Lactation, - Smoking, - Abnormal complete blood count; and - Alcohol consumption > 1 oz/day |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCDavis Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Juvenile Diabetes Research Foundation, National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HsCRP | |||
Primary | Monocyte function | |||
Secondary | Plasma biomarkers |
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